{"id":1706,"date":"2022-07-22T15:56:50","date_gmt":"2022-07-22T14:56:50","guid":{"rendered":"https:\/\/tris.sambrownprojects.com\/tris-pharma-announces-publication-of-study-results-highlighting-the-efficacy-and-safety-of-dyanavel-xr-amphetamine-tablets-for-the-treatment-of-the-symptoms-of-adhd-in-adults\/"},"modified":"2022-07-22T15:56:50","modified_gmt":"2022-07-22T14:56:50","slug":"tris-pharma-announces-publication-of-study-results-highlighting-the-efficacy-and-safety-of-dyanavel-xr-amphetamine-tablets-for-the-treatment-of-the-symptoms-of-adhd-in-adults","status":"publish","type":"post","link":"https:\/\/www.trispharma.com\/tris-pharma-announces-publication-of-study-results-highlighting-the-efficacy-and-safety-of-dyanavel-xr-amphetamine-tablets-for-the-treatment-of-the-symptoms-of-adhd-in-adults\/","title":{"rendered":"Tris Pharma Announces Publication of Study Results Highlighting the Efficacy and Safety of DYANAVEL\u00ae XR (amphetamine) Tablets for the Treatment of the Symptoms of ADHD in Adults"},"content":{"rendered":"
MONMOUTH JUNCTION, NJ, July 22, 2022 \/ PRNewswire\/ \u2013 Tris Pharma, Inc. (\u201cTris\u201d), a fully integrated pharmaceutical company with a robust portfolio of CNS products announced the publication of a Phase 3 study in the Journal of Clinical Psychiatry that demonstrated that adult patients with ADHD who took DYANAVEL XR (amphetamine) tablets CII had statistically significant improvement in symptoms over patients who took placebo.<\/p>\n
The study was a Phase 3, randomized, double-blind, placebo-controlled, fixed-dose study designed to assess the efficacy and safety of DYANAVEL XR tablets in adult patients with ADHD. The efficacy assessment included the administration of serial Permanent Product Measure of Performance (PERMP) tests pre-dose and at 0.5, 1, 2, 4, 8, 10, 12, 13, and 14 hours post dose. The mean PERMP Total (PERMP-T) score across all post dose time points \u2013 the primary efficacy endpoint \u2013 was statistically significantly higher in the DYANAVEL XR tablet group compared with placebo (302.8 vs 279.6; p=0.0043). Additionally, statistically significant improvements (increase) in PERMP-T scores were observed in the DYANAVEL XR tablet group at 0.5 hours (p=0.01), 1 hour (p< 0.001), 2 hours (p= 0.0003), 4 hours (p = 0.031), 8 hours (p = 0.026), and 13 hours (p=0.006) post dose compared with placebo. Numerical differences favoring the DYANAVEL XR tablet group were seen at the 10-, 12-, and 14-hour time points as well, however those differences were not statistically significant when compared to placebo. The most common adverse events included headache, decreased appetite, irritability, initial insomnia, insomnia, dry mouth, anxiety, dizziness, tachycardia, fatigue, and nausea. Most treatment-emergent AEs (TEAEs) were mild to moderate in severity, and no SAEs were reported during the study.<\/p>\n
\u201cThe results of this study demonstrate the efficacy of the amphetamine extended-release tablet in the treatment of ADHD in adults,\u201d said Andrew J. Cutler, MD, Clinical Associate Professor of Psychiatry, SUNY Upstate Medical University and the principal investigator of the study. \u201cWhen you look at the totality of the efficacy results, coupled with what we know about DYANAVEL XR pharmacokinetics and pharmacodynamics, you can see that the drug is working shortly after dosing, and is still providing efficacy 13 hours post dose.\u201d<\/p>\n
DYANAVEL XR employs Tris\u2019s unique LiquiXR\u00ae platform technology, which allows immediate-release products to be transformed into products with both immediate-release and extended-release characteristics and permits once-daily dosing.<\/p>\n
The article can be accessed here in the Journal of Clinical Psychiatry.<\/p>\n
About Tris Pharma<\/strong><\/p>\n Tris is a fully integrated, innovation-driven CNS company that provides a differentiated approach to target unmet medical needs, including the application of novel technologies designed to enhance patient benefits across therapeutic categories.<\/p>\n Tris\u2019s CNS portfolio includes treatments for pain; addiction; spasticity in multiple sclerosis, cerebral palsy; narcolepsy; and ADHD. For more information, please visit www.trispharma.com<\/a> and www.trismedical.com<\/a>.<\/p>\n DYANAVEL and LiquiXR are registered trademarks of Tris Pharma, Inc.<\/p>\n APPROVED USE It is not known if DYANAVEL XR is safe and effective in children under 6 years of age.<\/p>\n IMPORTANT SAFETY INFORMATION<\/strong> Tell your physician if you, your child, or any family members have ever abused or been dependent on alcohol, prescription medicines, or street drugs.<\/p>\n DYANAVEL XR should not be taken if you or your child<\/strong>\u202fare allergic to amphetamine or any of the ingredients in DYANAVEL XR, or are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.<\/p>\n DYANAVEL XR can cause serious side effects. Tell the doctor:<\/strong><\/p>\n Common side effects of amphetamine products include:<\/p>\n Talk to your doctor if you or your child have any side effects that bother you or do not go away.<\/p>\n Avoid drinking alcohol while taking DYANAVELXR.<\/p>\n You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov\/medwatch, or call 1-800-FDA-1088.<\/strong><\/p>\n Please see\u202fFull Prescribing Information<\/a>, including Boxed Warning about Abuse and Dependence, and\u202fMedication Guide<\/a>.<\/strong><\/p>\n References Pardo A, Kando JC, King TR, Rafla E, Herman BK. Single-dose pharmacokinetics of amphetamine extended-release tablets compared with amphetamine extended-release oral suspension. CNS Spectr. 2020;25(6):774-781. doi:10.1017\/S1092852919001676<\/p>\n Pardo A, King TR, Rafla E, Kando JC. Assessing Palatability of a New Amphetamine Extended-Release Tablet Formulation for the Treatment of ADHD. Drug Des Devel Ther. 2021;15:2979-2985. Published 2021 Jul 8. doi:10.2147\/DDDT.S309378<\/p>\n","protected":false},"excerpt":{"rendered":" Tris announces the publication of a Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study of DYANAVEL XR Tablets in Adults with ADHD in the Journal of Clinical Psychiatry. The article can be found here. The study demonstrated that DYANAVEL XR tablets are an effective and well-tolerated treatment for the symptoms of ADHD in adults. These results build on […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":"","_wp_rev_ctl_limit":""},"categories":[28],"tags":[],"class_list":["post-1706","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"acf":[],"featured_image_src":{"landsacpe":false,"list":false,"medium":false,"full":false},"yoast_head":"\n
\n<\/strong>DYANAVEL XR is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years and older. DYANAVEL XR may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.<\/p>\n
\nDYANAVEL\u202fXR is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep DYANAVEL\u202fXR in a safe place to prevent misuse and abuse. Selling or giving away DYANAVEL\u202fXR may harm others, and is against the law.\u202f<\/strong><\/p>\n\n
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\n<\/strong>Cutler AJ, Childress AC, Pardo A, et al. Randomized, double-blind, placebo-controlled, fixed-dose study to evaluate the efficacy and safety of amphetamine extended-release tablets in adults with attention-deficit\/hyperactivity disorder. J Clin Psychiatry. 2022; 83(00):22m14438. doi:10.4088\/JCP.22m14438<\/p>\n